AI is transforming drug discovery and development (3D) including clinical trials by increasing efficiencies, decreasing the gap between data and our ability to utilize data and most importantly making this journey patient centric. Non-invasive and non-intrusive animal and patient monitoring technologies lead and continue to lead development of novel digital biomarkers. Incorporation of digital endpoints and computational technologies into nonclinical and clinical trials leads to earlier and objective detection of physiological and behavioral changes, including off-target effects that lead to earlier decisions thereby reducing animal and patient burden. Leveraging recent advances in high-throughput technologies and machine learning provides an opportunity for more precise and more efficient target identification process. This talk will discuss these technologies and present their impact through case studies within clinical and nonclinical phases of 3D.